Adverse Events Following Immunization in Brazil: Age of Child and Vaccine-Associated Risk Analysis Using Logistic Regression

Abstract

Objective: Vaccines are effective in controlling and eradicating infectious diseases. However, adverse events following immunization (AEFI) can occur in susceptible individuals. The objective of this study was to analyze the Brazilian AEFI database and compare eight vaccines in order to profile risks of AEFIs related to the mandated pediatric schedule of immunization, considering the age and sex of the child, type of vaccine, and reported adverse events. Methods: We analyzed the Brazilian AEFI database integrating reports between 2005 and 2010 for children less than 10-years old immunized with eight mandated vaccines: diphtheria, pertussis, tetanus, Haemophilus influenzae type b (TETRA); diphtheria, tetanus, and pertussis (DTP); Bacillus Calmette–Guerin (BCG); oral poliovirus vaccine (OPV); measles, mumps, and rubella (MMR); oral rotavirus vaccine (ORV); hepatitis B (HB); and yellow fever (YF). We compared the children’s age regarding types of AEFI, evaluated AEFI factors associated with the chance of hospitalization of the child, and estimated the chance of notification of an AEFI as a function of the type of vaccine. In total, 47,105 AEFIs were observed for the mandated vaccines. Results: The highest AEFI rate was for the TETRA vaccine and the lowest was for the OPV vaccine, with 60.1 and 2.3 events per 100,000 inoculations, respectively. The TETRA vaccine showed the highest rate of hypotonic hyporesponsive episode, followed by convulsion and fever. The MMR and YF vaccines were associated with generalized rash. BCG was associated with enlarged lymph glands but showed the largest negative (protective) association with hyporesponsive events and seizures. Compared with children aged 5–9-years old, young children (<1 year) showed significantly higher odds of hospitalization. Conclusions: The Brazilian AEFI registry is useful to compare the magnitude and certain characteristics of adverse events associated with mandated pediatric vaccines.

Vaccines Safety in Children and in General Population: A Pharmacovigilance Study on Adverse Events Following Anti-Infective Vaccination in Italy

“…In our study, the most common AEFI related to vaccines were fever, injection-site reactions, rash, vomit, and fatigue, i.e., mild and transient untoward medical occurrences. Our results are comparable to those already published in literature, both in adults (Alguacil-Ramos et al, 2016; Mentzer et al, 2018) and in children (Danova et al, 2017; Lopes et al, 2018; Mentzer et al, 2018). We also reported six cases of febrile-related seizures (i.e., 1.05% of AEFI).…”

“…In terms of AEFI, our results are comparable with those published in the scientific literature over the past decades, both in adults (Alguacil-Ramos et al, 2016; Mentzer et al, 2018) and in children (Danova et al, 2017; Lopes et al, 2018; Mentzer et al, 2018). The adverse events related to the use of vaccines occur at a very low frequency and are generally irrelevant when compared to risks associated to non-vaccination (Aps et al, 2018).…”

Vigilância ativa de eventos adversos pós-vacinação na atenção primária à saúde

“…Embora a vigilância passiva consiga manter e alimentar um sistema de informação e seja um serviço de baixo custo, ela tem a desvantagem de subnotificar os eventos adversos pós-vacinação (9,12,14) e reduzir a sensibilidade para a identificação de novos casos, sinais ou mesmo novos tipos de eventos adversos. (15) Estudo observacional, realizado na região de Puglia, na Itália, mostrou que os serviços de saúde * Ajuste do modelo: qualidade do ajuste = 1,00; † regressão multivariada de Poisson (modelo ajustado por idade). RR -risco relativo; IC 95% -intervalo de confiança de 95%; dT -vacina contra difteria e tétano que realizam busca e vigilância ativa de eventos adversos pós-vacinação aumentam consideravelmente o número dessas notificações.…”

“…Isso se deve ao fato de a maioria das vacinas, por serem inativadas, exigir adjuvantes, geralmente derivados do alumínio, o que aumenta o risco de reações locais. (15) Nesse sentido, o profissional de saúde precisa ter conhecimentos teóricos e práticos para a administração de vacinas pela via intramuscular, para não incorrer em erros que possam gerar eventos adversos pós-vacinação e insatisfação do indivíduo vacinado. (14,25) Certas precauções devem ser tomadas ao administrar uma vacina por via intramuscular, considerando a composição corporal do indivíduo vacinado, o tamanho da agulha e o volume a ser administrado.…”

Toxicity evaluation of ConvitVax breast cancer immunotherapy

“…51 female BALB/c mice between 6 and 8 weeks of age were randomly divided into the 6 groups indicated in Table 1 . Since the BCG vaccine is widely used today as a tuberculosis vaccine and its adverse effects have been well studied 31 – 33 , following recommendations of the bioethics committee, we reduced the number of subjects in G3 to minimize the number of animals in the study. All mice received 100 μL of the corresponding treatment injected intradermal on the base of the neck once a week for 4 weeks, which was followed by a 4-week recovery period.…”